BARRIER N95 PARTICULATE RESPIRATOR

K102923 · Molnlycke Health Care · MSH · Nov 19, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K102923
• Device Name: BARRIER N95 PARTICULATE RESPIRATOR
• Applicant: Molnlycke Health Care
• Product Code: MSH · General, Plastic Surgery
• Decision Date: Nov 19, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The device is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Device Story

Barrier® N95 Particulate Respirators (Models #4272 and #4273) are disposable, non-sterile, flat-folded face masks. The device consists of three layers of non-woven fabric. An integrated aluminum filament nose clamp allows for contouring to the wearer's face, while ultrasonically welded elastic headbands secure the mask. The respirator functions as a physical barrier to reduce the transfer of microorganisms, body fluids, and particulates between the wearer and the environment. It is intended for use by operating room personnel during surgical procedures. The device is NIOSH-certified (TC-84A-4350) for particulate filtration efficiency.

Clinical Evidence

No clinical data was required. Substantial equivalence is supported by bench testing, including fluid resistance (ASTM F1862), flammability (16 CFR 1610), and NIOSH certification (TC 84A-4350) for particulate filtration, bacterial filtration, and differential pressure. Biocompatibility testing confirmed the device is non-cytotoxic, non-irritating, and lacks sensitization potential.

Technological Characteristics

Three-layer non-woven fabric (polypropylene/polyethylene); aluminum nose clamp; polyurethane headbands; ultrasonically welded. Trapezoid-folded design (duckbill when open). NIOSH-certified (TC 84A-4350). Meets ASTM F1862 (fluid resistance) and 16 CFR 1610 (flammability). Non-sterile.

Indications for Use

Indicated for operating room personnel during surgical procedures to protect patients and staff from microorganisms, body fluids, and particulate material.

Regulatory Classification

Identification

Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.

Special Controls

*Classification.* (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible. (ii) Analysis and nonclinical testing must: (A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and (B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device. (iii) NIOSH approved under its regulation. (2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

Predicate Devices

• Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 (K960778)

Submission Summary (Full Text)

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Image /page/0/Picture/13 description: The image shows the logo for Molnlycke Health Care. The logo consists of a cluster of five black circles on the left side, resembling a molecular structure or a group of cells. To the right of the circles, the text "MÖLNLYCKE" is stacked above "HEALTH CARE" in a simple, sans-serif font. The overall design is clean and professional, conveying a sense of scientific precision and healthcare focus.

-NOV-1-9-2010-

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c).

| Date Prepared: | November 1, 2010 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | Mölnlycke Health Care US, LLC<br>5550 Peachtree Parkway, Suite 500<br>Norcross, GA 30092 |
| Registration number: | 3004763499 |
| Owner/Operator Number: | 8030877 |
| Official Correspondent: | Caitlin Senter, MS, RAC<br>Regulatory Affairs Specialist<br>Tel: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| Trade/Proprietary Name: | Barrier® N95 Particulate Respirators, Models #4272 and #4273 |
| Common Name: | Particulate Respirator |
| Device Class: | Class II |
| Regulation Number: | 21 CFR 878.4040 |
| Product Code: | MSH |
| Predicate Device Name(s): | Gerson Isolair APR Type N95 Healthcare Particulate Respirator and<br>Surgical Mask Model 2735 (K960778) |

#### Description of Device:

Barrier® N95 Particulate Respirators. Models #4273 are NIOSH certified (TC-84A-4350), trapezoid shaped respirators. Barrier® N95 Particulate Respirators, Models #4273 consists of a flat folded disposable face mask that is a piece of three layered non-woven fabric folded in two. An aluminum filament is enclosed in a binding tape welding the top edge, which forms a conformable nose clamp for the purpose of shaping the mask to the contours of the face. It features elastic head bands, ultrasonically welded, to secure the masks in place for the wearer.

#### Intended Use/Indication for Use:

The devices are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

#### Technological Characteristics:

The Barrier® N95 Particulate Respirators, Models #4273 are substantially equivalent to the ISOLAIR APR Type N95 (K960778). Both devices have similar indications for use, materials, product design, and method of operation.

> Mölnlycke Health Care 5550 Peachtree Parkway, Suite 500 Norcross, GA 30092 USA

Tel [phone] Fax [phone] www.molnlycke.com

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Image /page/1/Picture/0 description: The image shows the logo for Molnlycke Health Care. The logo consists of five black circles clustered together on the left side of the image. To the right of the circles is the text "MÖLNLYCKE HEALTH CARE" in a simple, sans-serif font. The text is stacked, with "MÖLNLYCKE" on top and "HEALTH CARE" below it.

In the manufacture of these devices, multiple standards were utilized. ... The. Barrier® N95 Particulate Respirators, ... Models #4272 and #4273 characteristics are summarized below as compared to the requirements.

Characteristic

Fluid Resistance

Particulate Filtration Efficiency

Bacterial Filtration Efficiency

Differential Pressure

Flammability

Cytotoxicity

Irritation

Delayed-Type Hypersensitivity

#### Standard

The Barrier® N95 Particulate Respirators, Models #4272 and #4273 meet the requirements of ASTM F1862.

NIOSH Certification Number: TC 84A-4350 (Models #4272 and #4273)

NIOSH Certification Number: TC 84A-4350 (Models #4272 and #4273)

NIOSH Certification Number: TC 84A-4350 (Models #4272 and #4273)

The Barrier® N95 Particulate Respirators, Models #4272 and #4273 meet the requirements of 16 CFR 1610 Standard for Flammability of Clothing Textiles.

The Barrier® N95 Particulate Respirators, Models #4272 and #4273 are not cytotoxic.

The Barrier® N95 Particulate Respirators, Models #4272 and #4273 are not irritating.

The Barrier® N95 Particulate Respirators. Models #4272 and #4273 do not display any potential for sensitization.

> Mölnlycke Health Care 5550 Peachtree Parkway, Suite 500 Norcross. GA 30092 USA

Tel [phone] Fax [phone] www.molnlycke.com

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Image /page/2/Picture/0 description: The image shows the logo for Mölnlycke Health Care. The logo consists of a cluster of five black circles on the left, arranged in a triangular shape. To the right of the circles, the text "MÖLNLYCKE HEALTH CARE" is displayed in a sans-serif font, with "MÖLNLYCKE" on the top line and "HEALTH CARE" on the bottom line.

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______________________________________________________________________________________________________________________________________________________________________________ ------

---------The table below presents the similarities and differences of the technological characteristics between the Barrier® N95 Particulate Respirators, Models #4272 and #4273 and the predicate device, Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 (K960778).

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| Feature | Barrier® N95 Particulate Respirators,<br>Models #4272 and #4273<br>(Proposed Device) | Gerson Isolair APR Type N95 Healthcare Particulate<br>Respirator and Surgical Mask Model 2735<br>(Predicate Device) |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| 510(k) Clearance | TBD | K960778 |
| Manufacturer | Mölnlycke Health Care | LOUIS M. GERSON CO., INC |
| Common Name | Particulate Respirator | Particulate Respirator |
| Classification # | Class II | Class II |
| Classification Name | 21 CFR 878.4040 | 21 CFR 878.4040 |
| Product Code | MSH | MSH |
| Materials | | |
| Outer Material | Polypropylene | Polyester |
| Inner Material | Polyethylene/Polypropylene | Polyester |
| Filter Media | Polypropylene | Polypropylene |
| Nose Clamp | Aluminum | Aluminum/ PVC foam |
| Binding/cover Tapes | Polyester | |
| Head Bands | Polyurethane (blue), ultrasonically welded | Rubber (green), stapled |
| Specifications and<br>Dimensions | Small Mask<br>Length 205 mm ± 5 mm<br>Width 85 ± 5 mm<br>Band Length 190 ± 5mm | Medium Mask<br>Length 240 mm ± 5 mm<br>Width 85 ± 5 mm<br>Band Length 225 ± 5mm |
| | Length 140 mm ± 6 mm<br>Width 95 mm ± 6 mm<br>Height 64 mm ± 3 mm<br>Band Length (top) 318 mm ± 6 mm<br>Band Length (bottom) 260 mm ± 6 mm | |
| Mask Style | Trapezoid mask when folded,<br>Duckbill when open | Cup shaped |
| Design Features | Single use, flat folded, single use, disposable respirator<br>Longer vertical bottom length for more conformability<br>to wearer,<br>aluminum nose clamp to contour to the wearer | |
| | Single use, cup shaped respirator<br>Contoured nosepiece<br>Double stapled headstraps | |
| NIOSH certification | TC 84A-4350 (Models #4272 and #4273) | TC 84A-160 |
| Sterililty | Non-sterile | Non-sterile |
| Fluid Resistance | Pass | Pass |
| Particulate Filtration<br>Efficiency | NIOSH Certification Number: TC 84A-4350<br>(Models #4272 and #4273) | |
| | NIOSH Certification Number: TC 84A-160 | |
| Bacterial Filtration<br>Efficiency | NIOSH Certification Number: TC 84A-4350<br>(Models #4272 and #4273) | |
| | NIOSH Certification Number: TC 84A-160 | |
| Differential Pressure | NIOSH Certification Number: TC 84A-4350<br>(Models #4272 and #4273) | |
| | NIOSH Certification Number: TC 84A-160 | |
| Flammability | Pass | Not Known |

Mölnlycke Health Care 5550 Peachtree Parkway, Suite 500 Norcross. GA 30092 USA

Tel [phone] Fax [phone] www.molnlycke.com

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Image /page/3/Picture/0 description: The image shows the logo for Molnlycke Health Care. On the left side of the logo, there are five black circles clustered together. To the right of the circles, the text "MÖLNLYCKE HEALTH CARE" is written in black, with "MÖLNLYCKE" on the top line and "HEALTH CARE" on the bottom line.

# Performance-Data:- -----------------------------------------------------------------------------------------------------------------------------------------------------------

The performance data are summarized above.

#### Clinical Testing:

No clinical data was required.

#### Conclusion:

Based on the performance testing, it can be concluded that the Barrier® N95 Particulate Respirators, Models #4272 and #4273 are equivalent to the Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 (K960778) predicate with respect to intended use, materials, design, technological characteristics and performance.

> Mölnlycke Health Care 5550 Peachtree Parkway, Suite 500 Norcross. GA 30092 USA

> > .

Tel [phone] Fax [phone] www.molnlycke.com

.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Caitlin Senter Regulatory Affairs Specialist Mölnlycke Health Care US, LLC 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092

NOV 19 2010

Re: K102923

Trade/Device Name: Barrier® N95 Particulate Respirators, Models #4273, NIOSH Certification TC-84A-4350 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: November 1. 2010 Received: November 2, 2010

Dear Ms. Senter:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

ff your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.goy/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation

Center for Devices and Radiological Health

### Enclosure

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Image /page/6/Picture/0 description: The image shows the logo for Molnlycke Health Care. The logo consists of a cluster of five black circles on the left side, arranged in a way that they appear to be grouped together. To the right of the circles, the text "MÖLNLYCKE HEALTH CARE" is written in bold, uppercase letters.

K102923

| | INDICATION FOR USE | NOV 19 2010 |
|--|--------------------|-------------|
|--|--------------------|-------------|

| 510(k) Number (if known): | K102923 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Barrier® N95 Particulate Respirators, Models #4272 and #4273, NIOSH certification TC-84A-4350 |
| Indication for Use: | The device is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. |

| Prescription Use ______ | And/Or | Over the Counter Use X |
|-------------------------|--------|------------------------|
|-------------------------|--------|------------------------|

(21 CFR Part 801 Subpart D)

And/Or

X (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of

.

.

Elaine S. Mayhall

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

102923

510(k) Number:

Mölnlycke Health Care 5550 Peachtree Parkway, Suite 500 Norcross. GA 30092 USA

Tel [phone] Fax [phone] www.molnlycke.com